biolitec Clinical Study: Wound Healing by Laser Light

biolitec, Inc. is currently seeking investigators and subjects for a new clinical study to assess the efficacy of laser light at the 980 nm wavelength in healing all diabetic foot wounds. The selection process for qualified investigators is underway with the objective of establishing several study sites in the United States.

The study entails the application of laser light at the 980 nm wavelength—using the biolitec Ceralas D diode laser and a special collimating handpiece—to subjects’ wounds over the course of several weeks or until complete healing is achieved.

biolitec will provide individual investigators with funds for the recruitment of study subjects. In addition, biolitec is also offering other incentives to assist skilled, progressive podiatrists with the study and in the procurement of the Ceralas D laser.

Investigator responsibilities include: IRB and FDA approval prior to subject participation, receipt of subject informed consent, reporting of adverse reactions, accurate record keeping, and conducting the investigation in accordance with the investigational plan and FDA regulations.

To obtain an Investigator Application or for more information about previous wound healing studies completed by the Ohio College of Podiatric Medicine, please contact biolitec at 800-934-2377 or via email at woundhealstudy@biolitec.com.

Caution—Investigational device limited by federal law to investigational use.

Study Shows Hydrocolloid Dressings Heal Wounds More Expediently than Traditional Gauze-Type Dressings

As the population ages, healthcare costs multiply and financial demands strongly impact the quality of life. Examining the prevalence of chronic wound care, such as pressure and leg ulcers, and costs of their care suggest that their global burden is considerable and underscores that essential quality healthcare decisions must be made. The national cost of pressure ulcer treatment has been estimated to exceed $1.3 billion each year. Providers and payers must find ways to provide cost-effective care to persons with chronic wounds.

Several prominent medical authorities thought the subject important enough to publish “Cost and Cost Effectiveness of Venous and Pressure Ulcer Protocols of Care,” a meta analysis paper, in the November 2001 issue of Disease Management and Health Outcomes. Their objective was to explore the costs, outcomes, and effects of outcomes on costs of pressure and venous ulcer wound care protocols.

The authors, led by Morris D. Kerstein, MD, Chief of Staff, VA Administration Medical and Regional Office Center, Wilmington, Delaware, worked with respected health economics researchers from the Lewin Group to develop consensus-based economic models of pressure and venous ulcer care. Their models were based on best practices and an analysis of the published chronic wound literature. They concluded that wounds managed in a moist environment using hydrocolloid dressings heal more expediently than those covered with traditional gauze-type dressings. Moreover, they reported that defining wound care costs solely as the cost of products used is inaccurate and expensive.

Forty-nine percent of pressure ulcers and 61 percent of venous ulcers managed with gauze dressings remained unhealed after 12 weeks of care, while only 39 percent of pressure ulcers and 49 percent of venous ulcers managed with moisture-retentive dressings remained unhealed after 12 weeks. Wound management with lower-priced gauze became more expensive than that with hydrocolloid dressing due to increased dressing change frequency, which is a key driver of cost. Gauze management was 2.4 times as costly as management with the hydrocolloid dressing for pressure ulcers and 1.6 times as costly for leg ulcers.

The study was supported by an unrestricted grant from ConvaTec, a Bristol-Myers Squibb Company. For more information regarding this study, call Deborah Walter at 908-522-1677.

New Research Suggests Noncontact, Normothermic Wound Therapy (NNWT) is Effective in Healing Diabetic Foot Ulcers

Nonhealing foot ulcerations, secondary to diabetes, have been implicated in up to 90 percent of all amputations in several world centers, including the United States, Canada, England, Italy, Japan, Spain, and Taiwan. Prompt healing of ulcerations can prevent many of these amputations and likewise improved the quality of life for affected individuals. Approximately 2.35 million diabetic foot ulcers are diagnosed per year in the United States. The incidence of chronic wounds is expected to increase dramatically in the future due to the increasing incidence of diabetes and other health-related disorders associated with developing chronic wounds. The US diabetes rate alone may increase up to 165 percent over the next 50 years.

New developments in technology and more attention directed to the prevention of ulceration could reverse this tide. One therapy that may offer a promising direction is Warm-Up® therapy, manufactured by Augustine Medical. In a randomized, controlled trial of 36 patients, 13 (72%) of the 18 subjects in a group treated with noncontact, normothermic, wound therapy (NNWT, Warm-Up therapy) healed within the two-month time frame of this study. Five (28 percent) of the 18 subjects in the control group achieved complete healing. When wound warming was combined with offloading, wound healing rates improved to a statistically significant level (p = < 0.05) over that seen in individuals who received standard care and offloading.

While the study pointed out that Warm-Up therapy alone is not the answer to diabetic foot ulcers, it is a promising approach to improved wound healing. New technologies in addition to better wound care could bring the incidence of diabetic foot ulcers and amputations down significantly.

Warm-Up therapy is the only noncontact, normothermic wound therapy available today. The therapy is designed to assist the body’s healing process by maintaining warmth and humidity in the wound area. For more information on Augustine Medical and Warm-Up therapy, visit www.augustinemedical.com.

State-of-the-Art Clinical Approaches and Research Findings Presented at the First Annual Nutrition Week

Nutrition Week recently announced that state-of-the-art clinical approaches and research findings were presented at the first annual Nutrition Week, February 23–27, 2002, in San Diego, California. A comprehensive and multidisciplinary range of topics included obesity, nutrition, and chronic diseases, such as diabetes, heart disease, cancers and osteoporosis, neuropsychology, parenteral and enteral nutrition and nutrition support, micronutrients, phytoestrogens, nutraceuticals, and alternative therapies.

This Scientific and Clinical Forum combined the 26th Clinical Congress of the American Society for Parenteral and Enteral Nutrition (ASPEN), the 2002 Annual Meeting of the North American Association for the Study of Obesity (NAASO), with the scientific contributions from the American Society for Clinical Nutrition (ASCN), the American College of Nutrition (ACN), and six other nutrition-related professional organizations. With over 65 symposia on nutrition-related topics and over 525 original abstracts submitted, this international program could change the way we look at nutrition.

Nutrition Week was composed of nonprofit, membership-based, scientific, educational, or research-oriented nutrition associations and societies. Our mission was to enhance the understanding and collaboration among nutrition industry specialists, and raise the profile of nutrition within the healthcare community and general public. Attendees and participants were members of these organizations, practitioners with a related interest, and scientific leaders on the cutting edge of research and development. The resultant synergy from this first gathering and collaboration of nutrition scientists, dietitians, pharmacists, nurses, physicians, and healthcare professionals should have far reaching impact in scientific development, pharmaceutical discoveries, and patient care.

The convening organizations, ACN, ASPEN, ASCN, and NAASO, worked diligently to design and promote this international program to change the way we look at nutrition and health. For more information, visit www.nutritionweek.org.